Trauma InjuryTrICINCT03128658
Trauma Induced Coagulopathy and Inflammation
An observational study of Trauma Injury and Trauma, run by University of Pennsylvania at 1 site in United States.
Trial summary
While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Trauma, Coagulopathy
- What is being tested?
- Thromboelastography and Computational model
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma patients 18 years or older who present to the trauma bay as a trauma alert (highest level of activation), requiring blood product transfusion within 1 hour of admission, and/or having an injury severity score (ISS) greater than or equal to 15.
Who may be able to join
- Injured patients presenting to the trauma bay with a trauma alert activation (highest level of activation)
- Age 18 years old or more
Who cannot join
- Transfer duration to trauma service exceeding 6 hours.
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. In this prospective observational study, we will investigate the many factors that contribute to the development of trauma induced coagulopathy, post injury inflammation and the development of organ dysfunction in order to develop a multi scale computational algorithm of clinical prediction. Using a convenience sample technique, demographic data, physiologic data, blood samples and clinical variables will be collected over 5 days following traumatic injury. A computational model will be used to predict the development of TIC and multi-organ failure.
Read the detailed description
A prospective, observational, convenience sample of trauma patients 18 years old or older who present to the trauma bay as a trauma alert will be included after evaluation by the on-call trauma surgeon and research assistant. Minimally injured patients will be compared to those with a systolic blood pressure of 90 mmHg or less, the need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. Demographic data including past medical/medication history as well as clinical data including continuous vital signs will be recorded. If eligibility criteria are met, the research blood samples will be drawn at the same time as routine clinical samples. Blood samples (approximately 15 ml) will be taken on admission, 3hr, 6hrs, 12hrs, 24 hrs, 48 hrs, and 5 days post admission. Vital signs, number of blood transfusions, volume of crystalloid, administration of medications, and the values of routine laboratories will be monitored continuously for 24 hours, and then cumulatively for up to 5 days. After the last blood draw, we will be following the patient's outcome for up to 30 days. If patients are discharged or die prior to completing the 5 days of blood samples, additional samples and/or clinic appointments for the purpose of research will not be obtained. A computational algorithm will be used to predict the development of trauma induced coagulopathy, inflammation and multi-organ failure.
- Conditions
- Trauma Injury, Trauma, Coagulopathy
- Being tested
- Thromboelastography, Computational model
- Keywords
- Trauma induced coagulopathy
- Medical subject headings
- Accidental Injuries, Wounds and Injuries, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDiagnostic test
Thromboelastography (TEG) tests for parameters related to efficiency of blood coagulation. The parameters are: reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Computational modelDiagnostic test
The computational whole-patient systems model is a multiscale, multi-compartment model whose state-space is defined by a very large and heterogeneous set of variables as well as a large number of input parameters. The model will be integrated in time for various initial trauma conditions in an attempt to determine whether the model can be predictive, and help us discover new variables that are more predictive of clinical outcomes than those employed in current clinical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | Trauma patients with a systolic blood pressure of 90 mmHg or less, in need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. Receives: Diagnostic Test: Thromboelastography; Diagnostic Test: Computational model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thromboelastography parameters T0 -T3
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Measured: Between time of admission (T0) and 3 hours (T3)
Change in Thromboelastography parameters T3 -T6
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Measured: Between 3 hours (T3) and 6 hours (T6)
Change in Thromboelastography parameters T6 -T12
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Measured: Between 6 hours (T6) and 12 hours (T12)
Change in Thromboelastography parameters T12 - T24
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Measured: Between 12 hours (T12) and 24 hours (T24)
Change in Thromboelastography parameters T24 - T48
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Measured: Between 24 hours (T24) and 48 hours (T48)
Change in Thromboelastography parameters T48 - T120
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Measured: Between 48 hours (T48) and 120 hours (T120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start27 Feb 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Princeton University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128658
- Sponsor's protocol ID
- 826515
- Acronym
- TrICI
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Induced Coagulopathy and Inflammation
- ClinicalTrials.gov ID
- NCT03128658
- Acronym / sponsor ID
- TrICI / 826515
- Conditions
- Trauma Injury, Trauma, Coagulopathy
- Keywords
- Trauma induced coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Princeton University
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. In this prospective observational study, we will investigate the many factors that contribute to the development of trauma induced coagulopathy, post injury inflammation and the development of organ dysfunction in order to develop a multi scale computational algorithm of clinical prediction. Using a convenience sample technique, demographic data, physiologic data, blood samples and clinical variables will be collected over 5 days following traumatic injury. A computational model will be used to predict the development of TIC and multi-organ failure.
Detailed description
A prospective, observational, convenience sample of trauma patients 18 years old or older who present to the trauma bay as a trauma alert will be included after evaluation by the on-call trauma surgeon and research assistant. Minimally injured patients will be compared to those with a systolic blood pressure of 90 mmHg or less, the need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. Demographic data including past medical/medication history as well as clinical data including continuous vital signs will be recorded. If eligibility criteria are met, the research blood samples will be drawn at the same time as routine clinical samples. Blood samples (approximately 15 ml) will be taken on admission, 3hr, 6hrs, 12hrs, 24 hrs, 48 hrs, and 5 days post admission. Vital signs, number of blood transfusions, volume of crystalloid, administration of medications, and the values of routine laboratories will be monitored continuously for 24 hours, and then cumulatively for up to 5 days. After the last blood draw, we will be following the patient's outcome for up to 30 days. If patients are discharged or die prior to completing the 5 days of blood samples, additional samples and/or clinic appointments for the purpose of research will not be obtained. A computational algorithm will be used to predict the development of trauma induced coagulopathy, inflammation and multi-organ failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | – | Diagnostic Test: Thromboelastography, Diagnostic Test: Computational modelTrauma patients with a systolic blood pressure of 90 mmHg or less, in need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients 18 years or older who present to the trauma bay as a trauma alert (highest level of activation), requiring blood product transfusion within 1 hour of admission, and/or having an injury severity score (ISS) greater than or equal to 15.
Key inclusion criteria (2 listed)
- Injured patients presenting to the trauma bay with a trauma alert activation (highest level of activation)
- Age 18 years old or more
Key exclusion criteria (2 listed)
- Transfer duration to trauma service exceeding 6 hours.
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastographyThromboelastography (TEG) tests for parameters related to efficiency of blood coagulation. The parameters are: reaction time (R value), the K value, the angle and the maximum amplitude (MA) | Diagnostic test | Trauma patients |
| Computational modelThe computational whole-patient systems model is a multiscale, multi-compartment model whose state-space is defined by a very large and heterogeneous set of variables as well as a large number of input parameters. The model will be integrated in time for various initial trauma conditions in an attempt to determine whether the model can be predictive, and help us discover new variables that are more predictive of clinical outcomes than those employed in current clinical protocols. | Diagnostic test | Trauma patients |
Primary outcome
Change in Thromboelastography parameters T0 -T3
Time frame: Between time of admission (T0) and 3 hours (T3)
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T3 -T6
Time frame: Between 3 hours (T3) and 6 hours (T6)
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T6 -T12
Time frame: Between 6 hours (T6) and 12 hours (T12)
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T12 - T24
Time frame: Between 12 hours (T12) and 24 hours (T24)
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T24 - T48
Time frame: Between 24 hours (T24) and 48 hours (T48)
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T48 - T120
Time frame: Between 48 hours (T48) and 120 hours (T120)
Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and Trauma, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thromboelastography parameters T0 -T3 (time frame: Between time of admission (T0) and 3 hours (T3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.